Events

Retiro De Equipo (Recall) de Device Recall AMO WaveScan WaveFront System v3.65

Según U.S. Food and Drug Administration, este evento ( retiro de equipo (recall) ) involucró a un dispositivo médico en United States que fue producido por VISX INCORPORATED, A SUBSIDIARY OF AMO INC.

¿Qué es esto?

Una corrección al equipo o acción de retiro tomada por el fabricante para abordar un problema con un dispositivo médico. Los retiros (recalls) ocurren cuando un dispositivo médico está defectuoso, cuando puede poner en riesgo la salud, o cuando simultáneamente está defectuoso y puede poner en riesgo la salud.

Más información acerca de la data acá
  • Tipo de evento
    Recall
  • ID del evento
    47824
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-1695-2008
  • Fecha de inicio del evento
    2006-11-17
  • Fecha de publicación del evento
    2008-08-20
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2010-06-08
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=70284
  • Notas / Alertas
    U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
    The Parent Company was added by ICIJ.
    The parent company information is based on 2017 public records.
  • Notas adicionales en la data
    Excimer Laser System - Product Code LZS
  • Causa
    Firm became aware of a significant overcorrection in one eye of a patient who had received a wavefront-guided lasik treatment at a facility in germany. the probability of a recurrence of this error was determined to be extremely remote. to ensure that this type of incident will not happen again, a software update was developed.
  • Acción
    VISX issued a notification letter on November 27, 2006, to all distributors and direct accounts. The letter informed the recipients that they were performing a field correction in the form of a mandatory upgrade on all VISX WaveScan WaveFront Systems and Offline Programming Modules to correct an issue. The field upgrade should be made by February 16, 2007. A Dear Doctor letter was also issued instructing surgeons to upgrade all Offline Programming Modules using an enclosed CD.

Device

Device Recall AMO WaveScan WaveFront System v3.65
  • Modelo / Serial
    All systems with software version 3.65 and earlier: Part Numbers 0070-0150, 0070-0150R, 0070-1006, 0070-1006R, and 0070-1478.
  • Clasificación del producto
    Ophthalmic Devices
  • Clase de dispositivo
    3
  • ¿Implante?
    No
  • Distribución
    Class 2 Recall - Worldwide Distribution: USA, Venezuela, Colombia, Italy, Saudi Arabia, Kuwait, Egypt, UAE, Jordan, Lebanon, Australia, Canada, France, Germany, India, Ireland, Japan, Sweden, Vietnam, Czech Republic, Slovak Republic, Bulgaria, Philippines, South Korea, Turkey, UK, Portugal, Spain, Argentina, Israel, Cyprus, India, Mexico, Greece, Singapore, Chile, Poland, Brazil, China, Thailand, Taiwan, Hong Kong and Russia.
  • Descripción del producto
    Excimer Laser System; WaveScan WaveFront System, Software Version 3.65, for use with the VISX STAR S4 and STAR S4 IR Excimer Laser Systems. System is a diagnostic instrument intended for the automated measurement, analysis and recording of refractive errors and wavefront aberrations to the target shape and then generates the commands for the VISX STAR laser to create the target shape on the cones.
  • Manufacturer
    VISX INCORPORATED, A SUBSIDIARY OF AMO INC

Manufacturer

VISX INCORPORATED, A SUBSIDIARY OF AMO INC
  • Dirección del fabricante
    VISX INCORPORATED, A SUBSIDIARY OF AMO INC, 3400 Central Expy, Santa Clara CA 95051-0703
  • Empresa matriz del fabricante (2017)
    Johnson & Johnson
  • Source
    USFDA